MEDTECH, INDUSTRIAL IMPACT
Cybin | January 19, 2023
On January 18, 2023, Cybin Inc., a leading biopharmaceutical firm focused on advancing Psychedelics to Therapeutics®, announced the key findings from a feasibility study undertaken by its partner Kernel, which evaluated Kernel's Flow® wearable technology to assess ketamine's psychedelic effect on cerebral cortex hemodynamics. The findings of this Cybin-sponsored study are meant to guide the program's future direction.
The key highlights of the feasibility study are
It offered important proof-of-concept for Kernel Flow as a portable functional system that delivers real-time measurements of blood oxygenation changes in the brain linked with neural activity utilizing Time Domain Near Infrared Spectroscopy (TD-fNIRS).
Exhibited changes in functional brain biomarkers caused by ketamine that are related to potential therapeutic effects, including changes in cortical function associated with psychedelic experiences.
Compared to saline, ketamine reduces the global brain connectivity of the prefrontal region and decreases the brain-wide fractional amplitude of low-frequency fluctuations (fALFF). It has been proposed that fALFF is of particular functional significance within the default mode network, which has been demonstrated to be modulated by psychedelics and is associated with several neuropsychiatric conditions.
A model incorporating neurological and physiological metrics successfully predicted mystical experience scores on the Revised Mystical Experience Questionnaire, which has been shown to mediate reductions in depressive symptomatology in prior studies.
Displayed reliable pulse rate variability (PRV) and physiological measurements of pulse rate (PR) from TD-fNIRS recordings that correspond to those obtained from commercial external photoplethysmography sensors, thereby eliminating the need for external sensors to measure cardiac activity in future experiments.
Ketamine increased PR, decreased PRV, increased absolute oxy-hemoglobin concentrations and decreased deoxy-hemoglobin concentrations while increasing electrodermal activity (measured by an external sensor), providing additional physiological measures of the impact of the ketamine doses administered in the study.
The main goal of the feasibility study was to find out how people who had been given ketamine felt about wearing Kernel Flow while in an altered state of consciousness.
The feasibility study was granted FDA Investigational New Drug approval in October 2021 and US Institutional Review Board approval in January 2022.
Founded in 2019 and headquartered in Canada, Cybin is a biotechnology company that develops psychedelic pharmaceutical treatments for a variety of psychiatric and neurological disorders. It collaborates with a network of world-class partners and internationally recognized scientists to develop safe and effective treatments for patients dealing with a wide range of mental health conditions. The company is currently operating in the United States, Canada, the United Kingdom, Ireland, and the Netherlands.
INDUSTRIAL IMPACT, MEDICAL
SOPHiA GENETICS | January 13, 2023
SOPHiA GENETICSTM, a leading cloud-native software firm in the healthcare industry, recently announced that it has partnered with Memorial Sloan Kettering Cancer Center (MSKCC) to provide physicians and researchers with new testing and analytic capabilities.
The collaboration includes the incorporation of proprietary Comprehensive Genomic Panel (CGP) sequencing tests, such as MSK-ACCESS®, which SOPHiA GENETICS will market as the first comprehensive ctDNA liquid biopsy test powered by the SOPHiA DDMTM platform.
By integrating predictive algorithms, the power of the global SOPHiA GENETICS network, and the clinical knowledge of MSK in cancer genomics, specialists hope to broaden their access to capabilities for precision cancer analysis.
SOPHiA GENETICS and MSK will work together to further develop MSK-ACCESS®, ensuring that the solution leverages the advanced analytics of the SOPHiA DDMTM platform. The enhanced assay will be designed to align with the latest guidelines and clinical trial data reflecting major actionable biomarkers.
As part of this agreement, SOPHiA GENETICS plans to develop a new clinical-genomic, cloud-native analytics platform that enhances the impact of MSK’s extensive precision oncology data. This involves the application of sophisticated machine learning algorithms to examine vast amounts of multimodal data points to get new insights. The new SOPHiA CarePathTM module's goal, in conjunction with MSK's CGP sequencing assays, aims to improve cancer care worldwide.
About SOPHiA GENETICS
SOPHiA GENETICS is a cloud-native software company committed to establishing data-driven medicine as the standard of care and for life sciences research. It offers the SOPHiA DDM™ as a cloud-based SaaS platform that enables healthcare organizations to obtain quick and accurate insights from their data. The platform is currently being used by a broad network of hospitals, laboratories, and biopharma institutions globally. By applying its technology to diseases such as cancer and hereditary disorders, it facilitates the integration of genomic and phenotypic data, which is crucial for supporting discoveries, treatment decisions, and drug development activities. In addition, SOPHiA GENETICS supports its mission of bringing data analytics solutions to market through the global adoption of SOPHiA AI, built using techniques such as statistical inference, pattern recognition, and machine learning.
INDUSTRIAL IMPACT, MEDICAL
Genprex, Inc. | December 16, 2022
Genprex, Inc. a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced it has entered into an exclusive license agreement with
the University of Pittsburgh, granting Genprex a worldwide, exclusive license to certain patent applications and related technology and a worldwide, non-exclusive license to use certain related know-how, all related to modulating autoimmunity in Type 1 diabetes by using gene therapy. The preclinical technology transforms macrophages enabling them to reduce autoimmune activity in Type 1 diabetes and could be complementary to the Company's existing diabetes technology.
"Gaining exclusive access to technology that modulates the immune system by transforming macrophages could prove to be significant to our broader research partnership with the laboratory of George Gittes, MD, Professor of Surgery and Pediatrics and Chief of the Division of Pediatric Surgery at the University of Pittsburgh School of Medicine," said Mark Berger, MD, Chief Medical Officer of Genprex. "We are making significant strides in our program with Dr. Gittes's innovative approach to treating diabetes by the transformation of alpha cells into beta-like cells and are excited to add to our arsenal this additional technology also out of Dr. Gittes's lab, in collaboration with the laboratory of Dr. Xangwei Xiao, Assistant Professor of Surgery, also in the Division of Pediatric Surgery at the University of Pittsburgh's School of Medicine. Not only could this new approach be used to reduce autoimmune activity in Type 1 diabetes by modulating the immune system but potentially it could also work in conjunction with the technology we have licensed previously."
"With diabetes reaching epidemic proportions around the world, the work Dr. Gittes is pursuing in diabetes is absolutely critical. In the U.S. alone, there are more than 37 million people with diabetes and another approximately 96 million Americans who are pre-diabetic, or have abnormally elevated blood sugar levels. The opportunity to change the course of this disease with gene therapy is extremely compelling, and increasing our exclusive access to intellectual property could prove to be pivotal to our pathway forward,"
Rodney Varner, President and Chief Executive Officer of Genprex
The Company signed an exclusive license agreement with the University of Pittsburgh in 2020. The gene therapy approach under the original license is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, these genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body's immune system. In Type 2 diabetes, where autoimmunity is not at play, it is believed that exhausted beta cells will be rejuvenated and replenished.
This gene therapy approach was developed by Dr. Gittes. His preclinical research in this area has been published in peer-reviewed scientific publications, and he is the recipient of several research grants, including a $2.59 million grant awarded by the National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases.
Earlier studies in diabetic mouse models showed that the gene therapy restored normal blood glucose levels for an extended period of time, typically around four months. It is believed that the duration of restored blood glucose levels in mice could translate to decades in humans. Preliminary data from a more recent study in a non-human primate model of Type 1 diabetes also have been promising. Data from this study are expected to be presented at a scientific meeting during the first quarter of 2023.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches.